岗位描述(节选)
1. Health Authority Interactions & Regulatory Defense (FDA, EMA & NMPA)
•Serve as the primary technical presenter and defender for the pharmacometrics and clinical pharmacology package during formal milestone meetings with the U.S. FDA (e.g., End-of-Phase 2, Pre-NDA, Advisory Committee hearings), EMA and the China NMPA(CDE consultations).
•Lead the rapid strategy, execution, and authoring of techn……
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